PRI Cellular Modem, Australia, Canada
- Primary DI
- 00606959040403
- Brand
- PRI Cellular Modem, Australia, Canada
- Company
- Respironics, Inc.
- Model
- 00
- Catalog number
- 100215C
- Device description
- PRI Cellular Modem, Australia, Canada
- Published
- 2016-09-19
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| OUG | Medical device data system |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| OUG | Medical Device Data System | General Hospital | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00606959040403 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00606959040403 | 00606959040403 | 606959040403 | 0606959040403 |
GMDN Terms
| Term | Definition |
|---|
| Clinical laboratory information system | A dedicated assembly of devices designed to electronically receive, collect, store, display, output and distribute clinical laboratory information (e.g., transfer of digital images), within or between healthcare facilities, to support the administrative and clinical activities associated with clinical laboratory services and facilities. Some systems will also assist in data management/analysis. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded, and not directly used to run, steer, or control laboratory analysers or equipment). |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Humidity | 15 Percent (%) Relative Humidity | 95 Percent (%) Relative Humidity | |
| Storage Environment Temperature | -20 Degrees Celsius | 60 Degrees Celsius | |
| Storage Environment Temperature | -4 Degrees Fahrenheit | 140 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 080728314
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|
| 00606959055735 | Sleepware G3 | Sleepware G3 | | 2026-01-22 |
| 00606959060586 | Care Orchestrator | Care Orchestrator | | 2026-01-22 |
| 00606959424852 | DreamStation BiPAP autoSV | DreamStation BiPAP autoSV w/Humid w/H tube w/Cell, | AUX900T15C | 2017-02-01 |
| 00606959424944 | DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 AE w/Humidifier w/Cell, | AUX1131H15C | 2017-02-10 |
| 00606959424951 | DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 AE w/Cell, AU | AUX1131S15C | 2017-02-10 |
| 00606959424968 | DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 AE w/Humd w/H Tube w/Ce | AUX1131T15C | 2017-02-10 |
| 00606959424975 | DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 AE w/Humidifier w/WiFi, | AUX1131H15W | 2017-02-10 |
| 00606959424982 | DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 AE w/WiFi, AU | AUX1131S15W | 2017-02-10 |
| 00606959424999 | DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 AE w/Humid w/H Tube w/W | AUX1131T15W | 2017-02-10 |
| 00606959425378 | DreamStation | 01 | CNX1130T17 | 2019-12-29 |
| 00606959425385 | DreamStation | 01 | CNX1131H17 | 2019-12-29 |
| 00606959425392 | DreamStation | 01 | CNX1131S17 | 2019-12-29 |
| 00606959425408 | DreamStation | 01 | CNX1131T17 | 2019-11-20 |
| 00606959425484 | DreamStation BiPAP autoSV | DreamStation BiPAP autoSV w/Humid w/H Tube, w/Cell | CAX900T12C | 2017-02-01 |
| 00606959425491 | DreamStation BiPAP autoSV | DreamStation BiPAP autoSV w/Humid w/H Tube, w/WiFi | CAX900T12W | 2017-02-01 |
| 00606959425538 | DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 w/Humidifier w/Cell, CA | CAX1130H12C | 2017-02-10 |
| 00606959425545 | DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 w/Cell, CA | CAX1130S12C | 2017-02-10 |
| 00606959425552 | DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 w/Humid w/H Tube w/Cell | CAX1130T12C | 2017-02-10 |
| 00606959425569 | DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 w/Humidifier w/WiFi, CA | CAX1130H12W | 2017-02-10 |
| 00606959425576 | DreamStation BiPAP AVAPS | DreamStation BiPAP AVAPS30 w/WiFi, CA | CAX1130S12W | 2017-02-10 |
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